ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables
Device Facts
| Record ID | K162768 |
|---|---|
| Device Name | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables |
| Applicant | Integral Process Sas |
| Product Code | DSA · Cardiovascular |
| Decision Date | Aug 16, 2017 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.2900 |
| Device Class | Class 2 |
Indications for Use
Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.
Device Story
Device consists of reusable electrical cables, trunk cables, and leadwires; interfaces between patient-applied sensors (ECG electrodes, SpO2 probes, IBP transducers) and monitoring/diagnostic equipment. Cables conduct physiological signals from patient to monitor. Used in hospitals, clinics, emergency vehicles, and home environments; operated by healthcare professionals or patients. No active processing; passive signal transmission. Benefits include enabling connectivity between diverse OEM monitoring equipment and patient sensors. Healthcare providers use output (ECG, SpO2, BP waveforms/data) displayed on connected monitors for clinical assessment and decision-making.
Clinical Evidence
Bench testing only. Performance demonstrated through compliance with AAMI/ANSI EC53:2013, IEC 60601-1, IEC 60601-2-25, IEC 60601-2-27, ISO 80601-2-61, and IEC 60601-2-34. Biocompatibility testing performed per ISO 10993-1, ISO 10993-5, and ISO 10993-10.
Technological Characteristics
Reusable shielded/unshielded copper cables; medical-grade TPU jacket; medical-grade PA overmolded connectors. Includes trunk cables, leadwires, SpO2 interface cables, and IBP interface cables. Connectors include snap, clip, banana, and proprietary yoke configurations. Non-sterile. Complies with AAMI/ANSI EC53, IEC 60601-1, and ISO 10993 standards.
Indications for Use
Indicated for use with ECG, EKG, SpO2, and blood pressure monitoring/diagnostic equipment to facilitate signal conduction between patient-applied electrodes/sensors and the monitoring device. Intended for use in hospitals, doctor's offices, emergency vehicles, and home settings.
Regulatory Classification
Identification
A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.
Predicate Devices
- Shenzhen Med-link Electronics Tech Co., Ltd. Cable/lead-wire (K120010)
- Advantage Medical Cables, Inc. Patient Monitoring Cables (K992524)
- Unimed Medical Supplies, Inc. Patient monitoring Cables (K082959)
Submission Summary (Full Text)
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a family.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
INTEGRAL PROCESS SAS Virginie Grondin Quality & Regulatory Affairs Manager 12 Rue Des Cayennes Po Box B.P. 20310 Conflans Sainte Honorine, 78703 Fr
Re: K162768
Trade/Device Name: Integral-Process Medical Patient and Leadwire systems: ECG trunk cables, ECG leadwires, SpO - sensors interface cables and IBP transducers interface cables Regulation Number: 21 CFR 870.2900 Regulation Name: Cable, Transducer and Electrode, Patient, (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: July 7, 2017 Received: July 13, 2017
Dear Virginie Grondin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
M.A. Hillemann
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K162768
### Device Name
Integral-Process Medical Patient Cable and Leadwire Systems: ECG trunk cables, ECG leadwires, SpO2 sensors interface cables and IBP
## Indications for Use (Describe)
Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.
| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary
Administrative:
| Submitter: | INTEGRAL PROCESS SAS |
|------------|-----------------------------------------------------------|
| | Z.A. des Boutries |
| | 12, rue des Cayennes, B.P. 310 |
| | 78703 CONFLANS SAINTE HONORINE CEDEX, FRANCE |
| | Tel : +33 1 39 72 66 66 - Fax : +33 1 39 72 61 61 |
| Contact : | Virginie Grondin, Quality Manager, Official Correspondent |
| | Tel : +33 1 39 72 11 77 |
| | e-mail : vgrondin@integral-process.com |
Establishment Registration Number: 3004762958
Date of preparation: July 21, 2016
### I. Device Name:
| Classification Name: | Cable, transducer and electrode, patient, (including connector) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation description | Patient transducer and electrode cable (including connector) |
| Common/Usual Name: | Patient cables and Leadwires |
| Trade Name: | Integral-Process Medical Patient and Leadwire systems: ECG trunk<br>cables, ECG leadwires, SpO2 sensors interface cables and IBP<br>transducers interface cables. |
| Classification: | Class II |
|-----------------|----------|
| Registration #: | 870.2900 |
| Product Code: | DSA |
### II. Predicate Devices:
We have to consider the legally marketed closest existing devices to the Integral Process Medical Patient Cable and Leadwire Systems submitted devices and we will separate the following aspects:
Functionality (indication); Patient Usage; Positioning of the EKG/ECG Leadwires; Design and Shape; Cable Length; Materials; Sterility; Mechanical and Electrical Performance and Safety.
List of Predicate Devices:
| Substantial Equivalence | K # | Manufacturer / Current marketer | Device I/D |
|---------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EKG/ECG, SpO2, IBP Cables | K120010 | Shenzhen Med-link ElectronicsTech Co., Ltd.<br>Building2, HuaFu Ind. Park, HuaWang Road,<br>LongHua, BaoAn,<br>District 518109 Shenzhen City, P.R.China | Cable/ lead-wire (ECG, EKG, SpO2 and Invasive Blood Pressure) (*) |
| EKG/ECG, SpO2, IBP Cables | K992524 | Advantage Medical Cables, Inc.<br>10630 Wiles Road<br>Coral Springs, FL 33076 USA | Patient Monitoring Cables for ECG, EKG, Sp02 and Blood Pressure Monitors (*) |
| EKG/ECG, SpO2, IBP Cables | K082959 | Unimed Medical Supplies, Inc.<br>No.37, Yanshan Road, Shekou<br>Shenzhen, 518067 China | Patient monitoring Cables for ECG, EKG,Spo2 and Blood Pressure Monitors (*)<br>(*) Multiple References<br>See detailed catalogues and tables<br>Attachment I & III |
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| Comparison item | Integral-Process<br>Medical Patient Cable<br>and Leadwire systems | Shenzhen Med-link | Advantage medical | Unimed Medical |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | t.b.d. | K120010 | K992524 | K082959 |
| Indication | Integral-Process Medical<br>Patient Cable and<br>Leadwire Systems are<br>intended to be used with<br>various<br>electrocardiograph<br>recorders/monitors for<br>both diagnostic and<br>monitoring purposes<br>such as ECG, EKG,<br>SpO2 and Blood<br>Pressure equipment.<br>They are solely intended<br>to be used between the<br>electrode in contact with<br>the patient's skin and the<br>recording/monitoring<br>device. This cabling<br>facilitates the conduction<br>of signals between the<br>patient and the<br>monitoring device.<br>Integral-Process Medical<br>Patient Cable and<br>Leadwire Systems are<br>limited by the Indications<br>for Use of the connected<br>recording/monitoring<br>device. | Shenzhen Med-link<br>Cable / lead-wire are<br>intended to be used with<br>ECG, EKG, Sp02 and<br>Invasive Blood Pressure<br>monitoring devices. The<br>Cable / lead-wire are<br>used to connect<br>electrodes, catheters,<br>and/or sensors placed at<br>appropriate sites on the<br>patient to a monitoring<br>device for general<br>monitoring andfor<br>diagnostic evaluation by<br>heath care professional. | These patient cables<br>and leadwires are<br>intended to be used<br>with ECG, EKG, Sp02<br>and Blood Pressure<br>monitoring devices. | The Unimed patient<br>cables and lead wires<br>are intended to be used<br>with ECG, EKG, sp02<br>and BP monitoring<br>devices. The patient<br>cables and lead wire<br>are used to connect<br>electrodes, catheters,<br>and / or sensors placed<br>at appropriate sites on<br>the patient to a<br>monitoring device for<br>general monitoring<br>and/or diagnostic<br>evaluation by heath<br>care professional. |
| Patient Usage | Reusable | Reusable | Reusable | Reusable |
| Anatomical Sites | The leadwire is<br>connected to the ECG or<br>EKG electrodes placed at<br>standard specified<br>locations on the patient<br>limbs and/or chest. | The ECG and EKG<br>cable are attached to<br>sensors placed at<br>standard specified<br>locations on the chest<br>wall. | The ECG and EKG<br>cable are attached to<br>sensors placed at<br>standard specified<br>locations on the chest<br>wall. | The ECG and EKG<br>cable are attached to<br>sensors placed at<br>standard specified<br>locations on the chest<br>wall. |
| Design | ECG and EKG cables /<br>leadwires have various<br>designed connectors<br>(monitor, trunk yokes,<br>lead wire, electrode<br>grabber, snap and<br>banana) | ECG and EKG Cables<br>with various connectors<br>(monitor, trunk / lead<br>wire, electrode grabber<br>& snapper) | ECG and EKG Cables<br>with various connectors<br>(monitor, trunk / lead<br>wire, electrode grabber<br>& snapper) | ECG and EKG Cables<br>with various connectors<br>(monitor, trunk / lead<br>wire, electrode grabber<br>& snapper) |
| | Integral Process invasive<br>blood pressure cable has<br>various connectors (Yoke<br>type: on the transducer<br>side, instrument<br>connector on the other<br>side. | Invasive Blood Pressure<br>cables with various<br>connectors (Yoke type:<br>Utah 4pin, Instrument<br>connector: Spacelabs 6<br>Pin etc.) | Invasive Blood<br>Pressure cables with<br>various connectors<br>(Yoke type: Utah 4pin,<br>Instrument connector:<br>Spacelabs 6 Pin etc.) | Invasive Blood<br>Pressure cables with<br>various connectors<br>(Yoke type: Utah 4pin,<br>Instrument connector:<br>Spacelabs 6 Pin etc.) |
| Comparison item | Integral-Process<br>Medical Patient Cable<br>and Leadwire systems | Shenzhen Med-link | Advantage medical | Unimed Medical |
| | Integral Process SpO2<br>cable has various<br>connectors to connect<br>the OEM instrument<br>connector of SpO2<br>monitor and SpO2 probe.<br>(DB9, Din 8Pin, Philips,<br>etc.) | SpO2 adapter cables<br>with various connectors<br>for connect for the OEM<br>Instrument connector of<br>Sp02 monitor and Sp02<br>probe. (DB9, Din 8Pin<br>and Philips round 8Pin<br>etc.) | SpO2 adapter cables<br>with various connectors<br>for connect for the<br>OEM Instrument<br>connector of Sp02<br>monitor and Sp02<br>probe. (DB9, Din 8Pin<br>and Philips round 8Pin<br>etc.) | SpO2 adapter cables<br>with various connectors<br>for connect for the<br>OEM Instrument<br>connector of Sp02<br>monitor and SpO2<br>probe. (DB9, Din 8Pin<br>and Philips round 8Pin<br>etc.) |
| | Integral Process Medical<br>Patient Cable and<br>Leadwire Systems cover<br>a much larger range of<br>devices combining on<br>their both sides all type of<br>connectors than the<br>selected predicate<br>devices, without altering<br>either intended use or the<br>transfer signal<br>functionality. | | | |
| Cable Lengths | Various specified<br>standard lengths | Various specified<br>standard lengths | Various specified<br>standard lengths | Various specified<br>standard lengths |
| Wire material | Shielded & Unshielded<br>Copper; medical grade<br>TPU cable jacket with<br>medical grade PA<br>overmolded connectors<br>with integral strain relief. | Shielded & Unshielded<br>Copper with PVC or<br>TPU Jacket | Shielded & Unshielded<br>Copper with PVC<br>Jacket | Shielded & Unshielded<br>Copper with PVC<br>Jacket |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Connector Retention Force | ANSI / AAMI<br>EC53A:1998 (R)2001 | ANSI / AAMI EC53:1995<br>(R)2001 | ANSI / AAMI<br>EC53:1995 | ANSI / AAMI<br>EC53A:1998 (R)2001<br>EC53A-1998<br>(Amendment) |
| Electrical Performance and<br>Safety | ANSI / AAMI EC53:1995<br>(R)2001 | ANSI / AAMI EC53:1995<br>(R)2001 and IEC 60601-<br>1:1998; Am1; A2:1995 | ANSI / AAMI<br>EC53:1995 and IEC<br>60601-1:1998; Am1;<br>A2:1995 | ANSI / AAMI<br>EC53A:1998 (R)2001<br>and IEC 60601-1:1998;<br>Am1: A2:1995 |
# Comparison of cable / lead-wires has the same or similar technological characteristics as the Predicates:
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Representative samples of INTEGRAL PROCESS range of patient cables:
Although the total amount of the different cables presented in this submission is around 1260 part numbers we need a limited quantity of samples to have a good representation of the total range.
If we consider that cables have two ends and often an intermediate yoke we have defined 4 categories of connectors:
1) Monitor side connectors
All the INTEGRAL PROCESS cables connectors on monitor side can be represented with 8 types of connectors (From MC1 to MC8)
2) Intermediate connectors (Trunk cable yoke, IPB or SpO2 sensor side connector) All connectors can be represented with 8 different types of connectors (From YC1 to YC8).
Premarket notification: Integral-Process, Medical Patient Cable and Leadwire Systems
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# 3) Yoke side leadwires connectors
Four different types of connectors represent all the different leadwires connectors to the trunk cable yoke (From LY1 to LY4).
# 4) Patient side leadwires connexions
Four different types of connectors [Banana, Snap, Clip (with metal conductor) and Carbon Clip]. Those ends are on the patient side of the one piece ECG cables and of the detachable leadwires.
| Integral-<br>Process<br>Cable P/N | Description<br>(Connected Medical Equipment) | Predicate<br>Reference | Predicate<br>Name & K# | Monitor<br>side<br>connect<br>or | Middle<br>connexi<br>on | Connecto<br>r between<br>Leadwire<br>and<br>Trunk<br>cable<br>yoke | Patient<br>Side<br>Connect<br>or |
|-----------------------------------|----------------------------------------------------------------------------------|------------------------|------------------------|----------------------------------|-------------------------|--------------------------------------------------------------------|----------------------------------|
| 72279-US | NIHON KOHDEN CARDIOFAX OLD<br>GENERATION 5151-5303 | CB-72353P | Advantage<br>K992524 | MC1 | YC4 | | Banana |
| 71710-US | GE-MAC 1100 - 1200 MAC 400-<br>600-800 | CB-<br>721001R/1 | // | MC2 | YC2 | | |
| 72512-US | MEDTRONIC<br>PHYSIOCONTROLLIFEPAK 12 | CB-721007R<br>/1 | // | MC3 | YC4 | | Clip |
| 90797IP | MINDRAY DATASCOPE<br>BENEVIEW T5 - T8 IPM9800 D6 | S0125CO-L** | Shenzen<br>K120010 | MC4 | YC5 | | |
| 72240-US | NIHON KOHDEN BSM 2103-4103K | CB-713600 | Advantage<br>K992524 | MC5 | YC1 | | |
| 88769 | DRAEGER SIEMENS | CB-91018 | // | MC7 | YC7 | | |
| 87550 | GE EAGLE TRAM | BC-MC-MX1* | Unimed<br>K082959 | MC6 | YC6 | | |
| IPC71040 | BARD ELECTROPHYSIOLOGY<br>UNIT | CB-<br>721020R/1 | Advantage<br>K992524 | MC8 | YC3 | | |
| 90766IP | PHILIPS M3 - M4 - VSM MMS MP2<br>à MP70 | CB-A400-<br>1006VM | // | MC4 | YC8 | | |
| 71796-US | PHILIPS ECG100/200 Serie | CB-<br>721014R/1 | // | MC2 | YC3 | | Snap |
| 70626NGJ<br>3-US | 3 Leadwires for IP Trunk cables | LW-<br>3090R24/3A | // | | | LY1 | Snap |
| 70686NG-<br>US | Single IP Radiolucent leadwire | LW-<br>2300051/XA | // | | | LY3<br>carbon | Clip<br>carbon |
| 70822 | 3 Leadwires for IP paediatric trunk<br>cable | LW-<br>2090029/3A | // | | | LY2 | Snap |
| 70683HPJ<br>3-US | 3 Leadwires for PHILIPS Acquisition<br>Box: M1663A - M1668A - M1669A<br>– M1949A | LW-<br>2090S51/3A | // | | | LY3 | Clip |
| 70646WA<br>J10-US | 3 Leadwires WELCH ALLYN<br>ACQUISITION BOX: CP100 -<br>CP200 | EG040S5A** | Shenzen<br>K120010 | | | LY4 | Clip |
Substantial Equivalence by Selected (Sampling) References:
| Substantial<br>Equivalence | Integral Process<br>Device P/N | Predicate Device P/N | K # | Manufacturer / Current marketer |
|-----------------------------------|----------------------------------|--------------------------------------------|---------|-------------------------------------|
| ECG one piece and<br>trunk cables | 72512-US<br>72240-US<br>IPC71040 | CB-721007R /1<br>CB-713600<br>CB-721020R/1 | K992524 | Advantage Medical Cables Inc. (AMC) |
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| Substantial<br>Equivalence | Integral Process<br>Device P/N | Predicate Device P/N | K # | Manufacturer / Current marketer |
|------------------------------------|--------------------------------|----------------------|---------|-------------------------------------------------|
| ECG leadwires | 70626NGJ3-US | LW-3090R24/3A | K992524 | Advantage Medical Cables Inc. (AMC) |
| | 70686NG-US | LW-2300051/XA | | |
| | 70822 | LW-2090029/3A | | |
| | 70683HPJ3-US | LW-2090S51/3A | | |
| ECG leadwires<br>(cont) | 70646WAJ10-US | EG040S5A | K120010 | Shenzhen Med-link Electronics Tech<br>CO., Ltd. |
| EKG cables and<br>leadwires | 72279-US | CB-72353P | K992524 | Advantage Medical Cables Inc. (AMC) |
| | 71710-US | CB-721001R/1 | | |
| | 71796-US | CB-721014R/1 | | |
| SpO2 sensor<br>interface cables | 90797IP | S0125CO-L | K120010 | Shenzhen Med-link Electronics Tech<br>CO., Ltd. |
| | 90766IP | CB-A400-1006VM | K992524 | Advantage Medical Cables Inc. (AMC) |
| IBP transducer<br>interface cables | 88769 | CB-91018 | K992524 | Advantage Medical Cables Inc. (AMC) |
| | 87550 | BC-MC-MX1 | K082959 | Unlined Medical supplies Inc |
#### III. Device Description:
Integral-Process Medical Patient Cable and Leadwire Systems are electrical cables interfacing and connecting transducers/sensors/electrodes placed on patients, to monitoring/recording/diagnostic devices/equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use.
This cabling facilitates the conduction of signals between the patient and the monitoring/recording/diagnostic device.
Original Equipment Manufacturers (OEM) of either sides: e.g. sensors/captors/electrodes and monitoring/recording/diagnostic devices may be identical or different depending on source and period of supplies.
Integral-Process manufactures all type of interfacing transducer and patient cables, as replacement cables and/or as sub-contractor of main brands.
We can divide these Medical Patient Cable and Leadwire systems in 3 categories:
1) Electrocardiograph (EKG/ECG) cables (also sometimes referred to as trunk or lead wires) are replacements for similar cables manufactured by the OEM and other third party after market manufacturers for their respective monitors. The Trunk Cables connect the OEM patient monitor to the patient Lead Wires. The lead wires connect the trunk cable to the skin-mounted ECG electrodes. Additional Trunk Cables have a specific connector for Integral-Process proprietary pre-wired and harnessed electrode systems IP-SET
The most common cable configuration is of a 3, 5 or 10 conductors cable with a metal or plastic connector terminated on one end by crimp or solder method, using various keyway configurations depending on the make and model of the monitor, for connection to the monitoring device, and the 3, 5 or 10 conductors terminated into a connector or yoke assembly either for standard lead wires or for an IP-SET pre wired harness to attach on the other hand.
IP-SET® prewired harnessed electrodes are the object of a separate premarket notification file. (K101685)
{8}------------------------------------------------
Standard lead wires may be permanently attached to the yoke or terminated on one end with a 0.60 diameter pin and over molded with the mating DIN style connector and a snap or pinch type connector on the other hand for connection to the patient electrodes.
2) and 3) SpO2 and IBPT cables are connecting directly patient transducers and sensors to monitoring/recording/diagnostic equipment. The Integral Process manufactures a much larger range of cables combining on their both sides (Equipment, all type of patient connectors) than the selected predicate devices, without altering either intended use or the transfer signal functionality.
Although the total amount of the different cables presented in this submission is around 1260 part numbers we selected a limited quantity of samples to have a good representation of the total range, as shown above (Predicate Device Comparison)
### IV Conformance Standards
## Standards Applicable to Company
| cGMP (21 CFR 820) | QSR - Manufacturing |
|-----------------------|-------------------------------------------------|
| ISO 13485:2012 / 2003 | Quality System for Medical Device Manufacturing |
## Standards Applicable to Product
| 21CFR898 | PERFORMANCE STANDARD FOR ELECTRODE LEAD<br>WIRES AND PATIENT CABLES |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI EC53:2013 | ECG Cables and Lead Wires |
| ISO 14971 2007 | Medical devices - Application of risk management to medical<br>devices |
| IEC 60601-1: 1988 +A1 1991<br>+A2 1995<br>§ -56.3<br>IEC 60601-1<br>2005 / 2012 | Medical electrical equipment - Part 1: General requirements<br>for basic safety and essential performance: - Connectors<br>Medical electrical equipment - Part 1: General |
| IEC 60601-2-25:2011 | Particular requirements for the basic safety and essential<br>performance of electrocardiographs |
| IEC 60601-2-27:2011/AC1:2012 | Particular requirements for the basic safety and essential<br>performance of electrocardiographic monitoring equipment |
| ISO 80601-2-61:2011 | Particular requirements for basic safety<br>and essential performance of pulse oximeter equipment |
| IEC 60601-2-34:2011 | Particular requirements for the basic safety and essential<br>performance of invasive blood pressure monitoring<br>equipment |
| IEC 60601-2-49 2011 | Particular requirements for the basic safety and essential<br>performance of multi-function patient monitoring equipment |
| ISO 10993-1 | Biological evaluation of medical devices Part 1: Evaluation<br>and testing |
| ISO 10993-5 | Biological evaluation of medical devices Part 5: Tests for in<br>vitro cytotoxicity |
Premarket notification: Integral-Process, Medical Patient Cable and Leadwire Systems
{9}------------------------------------------------
### Biological evaluation of medical devices Part 10: Tests for ISO 10993-10 irritation and skin sensitization
### V Indications for Use
Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.
#### VI Comparison of Technological Characteristics
The Reusable Integral-Process Medical Patient Cable and Leadwire Systems are identical in function, and have the same intended use as the legally marketed disposable patient cables and leadwires that are intended to be used with ECG, EKG, Sp02 and Blood Pressure monitoring devices, from Shenzhen Med-link Electronics Tech CO., Ltd. (K120010), Unimed Medical Supplies Inc. (K082959) and Advantage Medical Cables Inc. (AMC) (K992524).
Other effectiveness and safety compliance (electrical safety and biocompatibility of skin-contact components) to required standards and requirements are demonstrated in the market authorization file.
Accordingly Integral-Process concluded that the Integral Process Medical Patient Cable and Leadwire Systems are as safe, as effective for their intended use and perform as well as or better than the legally marketed devices that are intended to be used with ECG, EKG, SpO2 and Blood Pressure monitoring devices.
